Curriculum Vitae: Hans Jonker

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1 Argonautenlaan LL Eindhoven The Netherlands GSM: +31 (0) Rabo: BTW: NL B01 CoC: Curriculum Vitae: Hans Jonker GENERAL Name Ir. J.J. Jonker (Hans) Function Senior Process Consultant Date of Birth 29 May 1958 Nationality Netherlands Language English, German Education Master at the Technical University of Twente (combination of): - Electronics - Biomedical Engineering - Computer Science Business Management EMPLOYERS 2008 now (ZZP / Owner) 2009 now DEKRA Quality (contractor) 2009 now Mikrocentrum (contractor) Sioux Embedded Systems (software house) High Tech Automation (software house) Océ van der Grinten LINKS Website: (incl. References of customers) LinkedIn:

2 Version: 1.11 Curriculum Vitae Page: 2/5 SUMMARY Experience Process Improvement Project Management International Experience Courses Soft Skills Expert in 14 years: Setting up Quality Management Systems 4 years: ISO years: Quality Assurance Officer 1 year: People Manager (HRM) 15 year: Software Development (Developer, Tester Manager, Project Manager) (28 years total: Product Development) Achieved with 2 organizations a very successful ISO certification Brought 3 organizations to the CMM(I) level 2, which operate according to that Quality System and still continuously improve!!. Performed 5 assessments on CMM(I) level 2/3. As ISO lead auditor performed about 38 audits As QA-Officer completed 2 years of auditing in development projects. As Process Improvement Coordinator guided a lot of QA-Officers to structure their auditing process. As a Project Manager organized 2 very successful projects. As a Process Improvement Coordinator guided a lot of Project Managers to structure their project management process. Worked 4 years in Germany and 3 years in Italy. Assessments done in Taiwan, Singapore and U.S.A. Medical Device (ISO-13485, Risk, Vigilance, CE-mark, FDA) Technical (Software, User Interfaces, Testing, ) Process Improvements Change Management Soft Skills SCRUM (Master) Prince 2 Communication Social / Interested in people Optimist Drive / Energy Setting up Quality Management Systems Software Development processes Change Management Peer Review Quality Assurance Project Management Supplier Management

3 Version: 1.11 Curriculum Vitae Page: 3/5 LATEST JOB DESCRIPTIONS Jun 2009 Now Certification Institute (Arnhem) Role Freelance ISO Lead Auditor Task Following the training traject to ISO Lead Auditor Performing ISO audits Results Performing ISO Audits (on average 1 per month) Apr 2009 Now Training Institute (Eindhoven) Role Freelance trainer Task Setting up courses on the area of Technical Product Development processes: o Overview Product Development Process o Quality Assurance in Projects o Document Reviews o Defining and using Metrics Giving these trainings (on average 1 per year) Apr 2008 Now Producer Medical Systems (Best) Role Senior Process Consultant Situation Within the CTO the group System & Software Performance Improvement (SSPI) exist, that coordinates the CMMI program for all Business Units. Task Stimulating the different BU s to share their Best Practices. Activities Setting up of a Website for the static information about the CMMI program Setting up of a SharePoint for sharing CMMI Best Practices Tools Intranet Publishing Service (IPS) MS-SharePoint Visio Result SSPI Website SSPI SharePoint Deployment to the involved CMMI project leaders

4 Version: 1.11 Curriculum Vitae Page: 4/5 Jan 2011 Nov 2012 Producer Pain Relief Patch (Eindhoven ) Role QMS-Manager SQM-Manager (a.i.) Situation The Venture (a separate group within the big organization to develop a completely new product) was developing a new product for relieving back pain. A couple of procedures of the Quality Management System were written. Task The tasks related to the ISO compliant Quality Management System has changed over time: 1. Reviewing of the already finished procedures 2. Supporting in writing procedures 3. Setting up the whole QMS Activities Setting up the process improvement infra-structure, including Process Owners for each Process Area Support the Process Owners by: o Training them in their Process Area o Setting up and writing procedures / templates o Tailoring of some adopted processes from other existing BU s o Setting up Training material Organizing of a training day for the whole team trained by the Process Owners Coaching and monitoring the project Organizing 2 preparation-audits Organizing the Certification Audit Supporting the CE-Certification (e.g. Essential Requirements, Technical File) Organizing a Supplier Audit by the CE-Certification institute Guiding the supplier with the production of the new product e.g.: o Production Process FMEA o Production Process Validation o Work Instructions o Training plan o Traceability Tools SubVersion / Trac FrontPage Result ISO certified Complete Quality Management System incl. templates and trainings material (in fact realized in 4 months) Intranet portal to the QMS

5 Version: 1.11 Curriculum Vitae Page: 5/5 Jul 2009 Dec 2012 Producer Laboratory Information Systems (Eindhoven ) Role Process Improvement Coordinator Situation The department has developed and maintained a very successful Laboratory Information Systems for many decades. The used Quality Management System however was not fully suited anymore for the actual situation. It was decided to make use of an existing Quality Management System of a colleague development group in Best and: to define tailoring rules to make the procedures suitable to setup an own subset of process / templates to give more room for their own specific situation Task To define a Quality Management System which is compliant with the ISO Activities Setting up the process improvement project (Brake!!) Coaching and monitoring the PIT-teams Training/Awareness of the team in the QMS Coaching and monitoring Maintenance and the projects Training and coaching of the new QA-Officer Tools SubVersion ClearQuest Quality Center Caliber Result Complete Quality System incl. tailoring rules, templates and trainings material Quality Management System which is compliant with the ISO Intranet portal to the QMS ISO certified (1 Minor NonConformity, 1 Observation, with compliments of the auditor) Jan 2011 Oct 2011 Producer of DNA Tests (Amsterdam ) Role Senior Software Process Consultant Situation The company was developing a software tool that could be used for analyzing the DNA test results, but was missing a documented Software Development Process. Task To define a simple Software Development Process which is compliant with the ISO Activities Training in Software Basics (e.g. Software Life Cycle, V-model) Setting up simple procedures and templates Guiding in using the new set of procedures and templates Tools MS-Office Result Software Development Process descriptions (incl. templates) according to the ISO and the IEC-62304, ready to be audited

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